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NCT Number: NCT07565649

Impact of Systematic Point-of-Care Ultrasound Implementation on Clinical Outcomes and Survival in Septic Shock: A Retrospective Single-Center Cohort Study

This study aims to evaluate the clinical impact of the systematic implementation of point-of-care ultrasound (POCUS) in the management of patients with septic shock in the intensive care unit (ICU).

Septic shock is associated with high morbidity and mortality, and its management requires timely and accurate hemodynamic assessment. Traditional monitoring methods have limitations in evaluating cardiac function, fluid responsiveness, and tissue perfusion. POCUS provides real-time, bedside, non-invasive assessment that may improve clinical decision-making.

This is a retrospective, single-center cohort study comparing two time periods: a pre-implementation cohort (2016-2019) and a post-implementation cohort (2022-2025), excluding the COVID-19 pandemic period. The primary objective is to assess whether the implementation of POCUS is associated with an improvement in early organ dysfunction, measured as the change in SOFA score at 48 hours (delta SOFA). Secondary outcomes include mortality at 28, 60, and 90 days, incidence of acute kidney injury, duration of organ support therapies, and length of ICU and hospital stay.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Admission to the intensive care unit (ICU) with a clinical diagnosis or suspicion of septic shock
  • Microbiological confirmation of infection during clinical course
  • Availability of data required to calculate SOFA score at ICU admission and at 48 hours

Exclusion criteria

  • ICU admissions during the period 2020-2021
  • Readmissions related to the same episode of septic shock
  • Missing data required for SOFA score calculation
  • Patients with limitation of life-sustaining therapies

Treatment and study plan

Primary outcomes

  1. Change in SOFA score at 48 hours (Delta SOFA)

    Time frame: Baseline (ICU admission) and 48 hours after ICU admission

    Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours.

Secondary outcomes

  1. 28-day mortality

    Time frame: Up to 28 days after ICU admission

    All-cause mortality within 28 days from ICU admission

  2. 60-day mortality

    Time frame: Up to 60 days after ICU admission

    All-cause mortality within 60 days from ICU admission

  3. 90-day mortality

    Time frame: Up to 90 days after ICU admission

    All-cause mortality within 90 days from ICU admission

  4. Incidence of acute kidney injury

    Time frame: From ICU admission to ICU discharge

    Occurrence of acute kidney injury during ICU stay

  5. Vasopressor-free days up to day 28

    Time frame: From ICU admission to day 28

    Number of days alive and free from vasopressor support within the first 28 days after ICU admission

  6. Mechanical ventilation-free days up to day 28

    Time frame: From ICU admission to day 28

    Number of days alive and free from mechanical ventilation within the first 28 days after ICU admission

  7. Renal replacement therapy-free days up to day 28

    Time frame: From ICU admission to day 28

    Number of days alive and free from renal replacement therapy within the first 28 days after ICU admission

  8. ICU length of stay

    Time frame: From ICU admission to day 28

    Length of stay in the intensive care unit

  9. Hospital length of stay

    Time frame: Through hospital discharge, an average of 28 days

    Total length of hospital stay

  10. Change in qSOFA score at 24 and 72 hours

    Time frame: Baseline (ICU admission), 24 hours, and 72 hours

    Change in quick Sequential Organ Failure Assessment (qSOFA) score at 24 and 72 hours from ICU admission

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

Impact of Systematic Implementation of Point-of-Care Ultrasound on Clinical Course and Survival in Patients With Septic Shock: A Retrospective Single-Center Cohort Study

Acronym: SHOCK

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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